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| Product NDC Code | 70000-0234 | ||||
|---|---|---|---|---|---|
| Drug Name | Extra strength antacid original flavor |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 308072 | ||||
| Application Number | part331 | ||||
| Labeler Name | Cardinal Health | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each tablet) Aluminum hydroxide 160 mg Magnesium carbonate 105 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions • chew 2 to 4 tablets four times a day or as directed by a doctor • take after meals and at bedtime or as needed • for best results follow by a half glass of water or other liquid • DO NOT SWALLOW WHOLE
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients alginic acid, calcium stearate, compressible sugar, flavor, sodium bicarbonate, starch (corn), sucrose.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses relieves • acid indigestion • heartburn • sour stomach • upset stomach associated with these symptoms
Purpose
Information about the drug product’s indications for use.Purpose Antacid Antacid
Spl product data elements
Usually a list of ingredients in a drug product.Extra Strength Antacid Original Flavor aluminum hydroxide and magnesium carbonate ALUMINUM HYDROXIDE ALUMINUM HYDROXIDE MAGNESIUM CARBONATE CARBONATE ION ALGINIC ACID CALCIUM STEARATE CORN SYRUP SODIUM BICARBONATE STARCH, CORN SUCROSE RP105 ORIGINAL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel LEADER™ NDC 70000-0234-1 COMPARE TO GAVISCON ® EXTRA STRENGTH ANTACID active ingredients* Extra Strength Antacid Tablets Aluminum Hydroxide, 160 mg Magnesium Carbonate, 105 mg Original Flavor Helps Keep Acid Down for Hours Fast-Acting Heartburn Relief 100 Chewable Tablets 100% Money Back Guarantee DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING ©2018 Cardinal Health. All Right Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 All LEADER™ Brand Products Have A 100% Money Back Guarantee. Return to place of purchase if not satisfied. This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademarks of Gaviscon ® Extra Strength Antacid. Extra Strength Original Flavor Antacid Tablets Aluminum Hydroxide, Magnesium Carbonate
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information • Each tablet contains: magnesium 31 mg, sodium 19 mg • Store at room temperature.
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are • taking a prescription drug. Antacids may interact with certain prescription drugs • If you are on a sodium-restricted diet
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately. 1-800-222-1222
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product • do not take more than 16 tablets in 24 hours • do not use the maximum dosage for more than 2 weeks
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Consuming this product can expose you to chemicals including lead, which is known to the State of California to cause cancer. For more information, go to www.P65Warningd.ca.gov Ask a doctor or pharmacist before use if you are • taking a prescription drug. Antacids may interact with certain prescription drugs • If you are on a sodium-restricted diet When using this product • do not take more than 16 tablets in 24 hours • do not use the maximum dosage for more than 2 weeks Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately. 1-800-222-1222
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API